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U.S. Department of Health and Human Services

Class 2 Device Recall Universal Clamp System

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 Class 2 Device Recall Universal Clamp Systemsee related information
Date Initiated by FirmFebruary 12, 2016
Create DateMarch 18, 2016
Recall Status1 Terminated 3 on August 11, 2016
Recall NumberZ-1189-2016
Recall Event ID 73363
Product Classification Orthosis, spinal pedicle fixation, for degenerative disc disease - Product Code NKB
ProductUniversal Clamp System (IFU reference: SNA027-N-90001). Provides the stability required for solid bone fusion and helps reduce spinal deformities and fractures.
Code Information All lots
Recalling Firm/
Manufacturer		 Zimmer Spine, Inc.
7375 Bush Lake Rd
Minneapolis MN 55439-2027
For Additional Information ContactCustomer Service
866-774-6368
Manufacturer Reason
for Recall		Zimmer Biomet is initiating a Medical Device Correction Notice to provide updated cleaning and disinfecting instructions for use of the Instinct Java System (IFU reference: 046WAN0000T) and Universal Clamp System (IFU reference: SNA027-N-90001).
FDA Determined
Cause 2		Process control
ActionConsignees were sent on 2-12-2016 a Zimmer Biomet "Urgent Medical Device Correction Notice" letter dated February 12, 2016. The letter was either addressed to Hospital Representative or to Distributors, Sales Representatives, and Distribution Operations Managers. The letters described the problem and the product involved in the recall. Advised consignees to immediately utilize the updated and attached Instructions For Use. Requested consignees to complete the "Acknowledgement of Field Notification" form. For questions contact Customer Service at 1-866-774-6368 or e-mail corporatequality.postmarket@zimmerbiomet.com.
Quantity in Commerce3484
DistributionUS (nationwide)-including the states of AL, AZ, AR, CA, CO, FL, GA, ID, IL, IN, IA, LA, ,MD, MA, MI, MN,MO, NV, NH, NY, NC, OH, OK,. PA, TN,TX, WA, and WI.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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